About me
My name is Michelle Riddalls and I am a commercially and strategically aware Regulatory Consultant, with 15 years of Regulatory Affairs experience, 12 of which in the OTC sector.
I am an organised leader with the proven ability to manage others to reach key objectives. I have strong decision making, problem solving and planning skills. I am an excellent cross functional team player and I am used to developing and implementing innovative solutions. I have highly effective communication skills and have the ability to influence key internal and external stakeholders, both nationally and internationally.
My Key Skills and Achievements
- Ensuring marketing authorisation approval and implementation of changes within critical business timelines
- Cross functional team work with the ability to lead and manage people in both New Product Development (NPD) and Product Changes
- Managed and completed specific special projects on a regular basis e.g. User Testing, Change of Name and Address
- Using initiative and strategic thinking to develop and implement effective solutions to problems and aid NPD and product approvals
- Strong interpersonal and communication skills, used to influence agencies, external and internal stakeholders and colleagues nationally and internationally to align to key commercial deadlines and project requirements
- Planning and organising workload, using project management skills
- Coordination of projects and input into working groups with industry association PAGB
- Identify process improvements and write new and efficient operating procedures to support the changes
- Audit management and preparation
- Writing position papers on latest UK government initiative "Red Tape Challenge"
Technical and Specialised Skills
Strategic advice on NPD and Product Changes | Rebrands and artwork, including Patient Information Leaflets writing | Reclassifications of medicines POM to P and P to GSL |
SOP writing | Manufacturing transfers | Reformulations |
MA submissions and responses | Systems and Process Optimisation, Management and Training | Documentum Management – design, management and validation |
Position Papers | User Testing | Project Management of major changes to products |